Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing
I thank Jonathan Leo for his comments on my article. Leo and his colleagues have been pioneering critics of industry publications practices, and of the weaknesses in the current ICMJE guidance.(1) Their work is an significant point of reference in this field of ethics.
I concur with Leo’s comments, and highlight in particular his point that if writers who draft manuscripts are not listed as coauthors, then it is not only an injustice, but prevents reporting of their interests and lessens the overall visibility of industry’s role in the attribution, disclosure and indexing of the published work.
As my article relates, however, there are many conduits by which companies influence manuscripts and through which commercial bias may on some occasions enter the literature. Manuscript writing is one such conduit (notwithstanding the honesty and professionalism of the writers themselves) but so is simpler editing of manuscripts. Most commercial clinical trial manuscripts also include company employees as coauthors, and here too there is a means for the company’s perspectives to be reflected in the published article, whether these perspectives are objective and appropriate, or whether they are swayed by commercial interest. I list other conduits in my article, using the analogy of a “tool kit” by which companies in various ways can steer the content of manuscripts, and through which bias, which need not be conscious, may find its way into some industry literature.
The positive affirmation of one’s own research findings is a problem that has been documented in noncommercial as well as commercial research.(2) It is a greater problem in commercial research, however, because of its clear relationship with marketing and sales. The issue my article focuses on is not primarily, however, the risk of bias, but simply the need to ensure that the attribution of commercial literature truly reflects its provenance. There is much objective and important industry research, but commercial involvement and interests must be brought more conspicuously to the attention of readers than the current culture of attribution within medicine allows for. The inclusion of writers as coauthors when they draft manuscripts is one part of this, but more importantly, the overall system by which journal literature is attributed, labelled and indexed requires overhaul.
Finally, I agree with Leo that the ICMJE authorship requirements need revising, such that whoever drafts the manuscript or edits it extensively for intellectual content is required to be a coauthor. The case for this approach is now compelling, and it would put an end to the confusion over whether ghostwriting is a matter of nondisclosure of the individual who wrote the draft, or whether, as ghostwriting should correctly be considered, a matter of nonauthorship.
2. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010;303:2058-64
Competing interests:
I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. As stated in my article, between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.
Rapid Response:
Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing
I thank Jonathan Leo for his comments on my article. Leo and his colleagues have been pioneering critics of industry publications practices, and of the weaknesses in the current ICMJE guidance.(1) Their work is an significant point of reference in this field of ethics.
I concur with Leo’s comments, and highlight in particular his point that if writers who draft manuscripts are not listed as coauthors, then it is not only an injustice, but prevents reporting of their interests and lessens the overall visibility of industry’s role in the attribution, disclosure and indexing of the published work.
As my article relates, however, there are many conduits by which companies influence manuscripts and through which commercial bias may on some occasions enter the literature. Manuscript writing is one such conduit (notwithstanding the honesty and professionalism of the writers themselves) but so is simpler editing of manuscripts. Most commercial clinical trial manuscripts also include company employees as coauthors, and here too there is a means for the company’s perspectives to be reflected in the published article, whether these perspectives are objective and appropriate, or whether they are swayed by commercial interest. I list other conduits in my article, using the analogy of a “tool kit” by which companies in various ways can steer the content of manuscripts, and through which bias, which need not be conscious, may find its way into some industry literature.
The positive affirmation of one’s own research findings is a problem that has been documented in noncommercial as well as commercial research.(2) It is a greater problem in commercial research, however, because of its clear relationship with marketing and sales. The issue my article focuses on is not primarily, however, the risk of bias, but simply the need to ensure that the attribution of commercial literature truly reflects its provenance. There is much objective and important industry research, but commercial involvement and interests must be brought more conspicuously to the attention of readers than the current culture of attribution within medicine allows for. The inclusion of writers as coauthors when they draft manuscripts is one part of this, but more importantly, the overall system by which journal literature is attributed, labelled and indexed requires overhaul.
Finally, I agree with Leo that the ICMJE authorship requirements need revising, such that whoever drafts the manuscript or edits it extensively for intellectual content is required to be a coauthor. The case for this approach is now compelling, and it would put an end to the confusion over whether ghostwriting is a matter of nondisclosure of the individual who wrote the draft, or whether, as ghostwriting should correctly be considered, a matter of nonauthorship.
References
1. Leo, J, Lacasse, J.R., and Cimino, A.N. Why Does Academic Medicine Allow Ghostwriting? A Prescription for Reform. Society 2011. Accessed at: http://diginole.lib.fsu.edu/islandora/object/fsu:252737/datastream/PDF/view 3 October 2016.
2. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010;303:2058-64
Competing interests: I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. As stated in my article, between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.